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APPLICANT’S ETHICS CHECKLIST
This checklist is designed to help you to decide whether or not ethics approval is required and, if
required, to decide on the appropriate ethics review procedure –
please read guidance on page 5 before you complete the form
Who should use the checklist?
A checklist should be completed for all empirical research projects involving people, by the Principal
Investigator [PI] or the Principal Supervisor [PS] in the case of a supervised student research project.
Guidance on the 2 different ethics review procedures that together make up the University’s Ethics Review
System (i.e. ‘University’ and ‘NHS’) is available on the University Ethics website
If the project involves human tissue/biological fluids you should contact the University human tissue bank
for advice in the first instance. Contact Ethical Tissue on 01274 235897 or visit www.ethicaltissue.org
____________________________________________________________________________
Project Title:……………………………………………………………………………………………
Name of Principal Investigator / Principal Supervisor: .……………………………………...
Contact Details – email address ……………………………………………………………………
Department/School ………………………………………………………………………………….
Name of Student (if applicable):.………………………………………. ……… ……………….
Contact Details – email address ……………………………………………………………………
Summary
ofPROJECT
Project (max
150150
words):
SUMMARY
OF
(max
words)
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YES/NO
Q1
Is the proposed project an empirical research project involving people?
 will the project include primary data collection from human subjects, their data or
their tissue?
 Will it constitute an ‘investigation undertaken in order to gain knowledge and
understanding’?
(this includes work of educational value designed to improve understanding of the
research process)
A more detailed definition of Research, Audit and Service Evaluation is available on the
University Ethics website.
If you answer ‘Yes’ to Q1 ethical approval may be required, move to Q2.
If you answer ‘No’ to Q1 then a research ethics review is not required.
Note: there may be occasions where a project is not defined as research but still raises
ethical issues – please submit for review in these cases.
Q2
Will the research project involve the NHS?
See See guidelines on the University Ethics website
If you answer ‘No’ to Q2 move on to Q3
If you answer ‘Yes’ to Q2 ethical approval will be required by NHS Research Ethics
Committee (REC)
Contact Ethical Tissue on 01274 235897 or visit www.ethicaltissue.org
YES/NO
Q3
YES/NO
Will the research project involve any of the following in the UK:
 Testing a medicinal product
 Investigating a medical device
 Taking samples of human biological material (e.g. blood, tissue)
 Prisoners or others in custodial care (e.g. young offenders) as participants
 Adults with mental incapacity as participants
 Other vulnerable groups (e.g. vulnerable children) as participants
If you answer ‘Yes’ to Q3 ethical approval will usually be required by Ethical Tissue or
NHS Research Ethics Committee (REC) or where the project includes participants which
need approval under the Mental Capacity Act approval will be required by the Social Care
REC.
See information specific to research in Social Care on the University Ethics website
If you answer ‘No’ to Q3 move on to Q4
Q4
Will the research project involve human participants and/or human data (but not
accessed through the NHS)?
YES/NO
If you answer ‘Yes’ to Q4 University ethical approval is required unless data/participation
is uncontentious (see guidance overleaf)
If you answer ‘No’ to Q4 move on to Q5
Please give brief explanation below of type of data/participation in cases which you
consider to be uncontentious (see guidance on page 5):
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Ethics Checklist - page 3
Q5
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Will the research project involve human tissue (but not requiring NHS approval –
see Q3)?
YES/NO
If you answer ‘Yes’ to Q5 University ethical approval is required
If you require advice on human biological material please contact Human Tissue Act
(HTA) Designated Individual: Professor Diana Anderson on ext 3569 or email:
d.anderson1@bradford.ac.uk)
Contact Ethical Tissue on 01274 235897 or visit www.ethicaltissue.org
Q5a
If you answered ‘Yes’ to Q5, is the human material over 100 years old and
archaeological?
YES/NO
If ‘YES’ please refer to the Biological Anthropology Research Centre (BARC) guidelines at
http://www.barc.brad.ac.uk/BARC_human_remains_policy.pdf
If you answer ‘No’ to Q5 and have answered ‘No’ to Q2, Q3 and Q4 ethical approval is not required.
PLEASE COMPLETE and SIGN ONE of the boxes below:
1. I have discussed this project with my student and
2. confirm that there are no ethical issues requiring further consideration.
(Any subsequent changes to the nature of the project will require a review of the ethical
considerations)
Name (Principal Investigator/Principal Supervisor):
Signature:
Date:
Name (Student):
Signature:
Date:
I confirm that there are ethical issues requiring further consideration and will refer the proposal
either to Ethical Tissue or fill in and submit a full ethics application to be considered by the
appropriate Research Ethics Panel..
Name (Principal Investigator/Principal Supervisor):
Signature:
Date:
Checked by Chair of Research Ethics Panel
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Annex 1
Ethical Scrutiny by a University Research Ethics Panel is not required if:

The project is NOT a research project.

The research project will only involve unlinked or aggregated human data which was
collected and which was, at the time, subject to relevant research ethics panel
approval.
However, where this is the case the researcher should at least confirm this in an email to the
Research Support Unit’s Ethics Administrator so that the Ethics Administrator has a record
and can inform the Chair of the appropriate Research Ethics Panel that the researcher plans
to go ahead without ethics approval. The email should confirm that the research project
does not require ethics approval because it only involves unlinked or aggregated data,
which when originally obtained from people was obtained in accordance with the protocol as
approved at the time by an appropriate research ethics panel. The email should also briefly
explain how the researcher now plans to use the unlinked or aggregated data.

The research is Public Domain Data:
The Economic and Social Research Council’s (ESRC) Research Ethics Framework states
that ethics approval may not be required for data sets that exist in the public domain (e.g.
datasets that are available from the Office for National Statistics or from the ESRC’s Data
Archive) so long as the appropriate permissions from individuals have already been
obtained (i.e. informed consent) and where it is not possible to identify the individuals from
the information provided. It must be remembered that public domain data is still covered by
the laws of copyright.

The research involves Simple Uncontentious Questionnaires:
If a research project’s only involvement with human subjects is a simple brief questionnaire
with uncontroversial content it may not require ethical approval. It is the Principal
Investigator or Principal Supervisor’s responsibility to decide whether a project comes under
this category and must indicate this on the form and attach the document for information.
Guidance on supervisor and principal investigator sign off of uncontentious research
Audit and service evaluation are usually uncontentious, and guidance on how to differentiate
between research, audit and service evaluation is given at: University Ethics website.
Even where a project is clearly research, as a supervisor or principal investigator, you can sign off
simple, ethically uncontentious projects as not needing further ethical scrutiny. To do this, you
should consider the level of risk to participants and researchers, the level of effort required by
participants, the level of intrusion into participants’ lives and the level of sensitivity of both the
general subject matter and the information requested of participants. Basically, the lower these
levels, the more likely the research is to be uncontentious and the more confident you should feel
about signing off.
The following examples may help.
These studies can almost always be signed off by the supervisor or principal investigator:



Brief questionnaires asking opinions about matters which are clearly not sensitive (attitudes to a
product, beliefs about the usefulness of a course).
Brief interviews about such topic.
Observational studies about everyday behaviour in public places which involve no risk to
subjects or the researcher.
But the following studies almost always need further scrutiny by a University Ethics Panel:
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Long questionnaires (these require considerable potential inconvenience to subjects).
Long interviews
Any questionnaires which ask subjects about intimate behaviours or issue likely to cause
distress or would in other ways normally be regarded as contentious or sensitive (e.g. illegal
activities, attitudes to abortion, capital punishment, immigration, euthanasia).
Any interviews which examine these matters.
Observational studies which involve intimate behaviours, behaviours which are not normally
public or which might normally be considered contentious or sensitive (Activities of ethics
committees, appointment committees, etc; professional consultations).
Naturally, this list is for illustration only, and should not be considered in any way exhaustive,
permissive or prescriptive. For example, there are many categories of research not mentioned here
which would definitely require ethics approval (e.g. treatment research). Rather the list
demonstrates the issue of proportionality. Thus, even though the method may be the same for
activities requiring and not requiring further scrutiny, the content in some way distinguishes between
the two categories.
At the same time, there is obviously some middle ground. Are ethics committees not public? Is
what is discussed so sensitive that the proposal needs further scrutiny? What about asking people
about their views on the actions of senior members of staff in their organisation? Probably, it is in
these middle ground areas that further advice should be sought from a Panel Chair about whether
the project can be signed off by the supervisor or principal investigator alone. Given that, in so
doing, the supervisor or PI is attesting to the ethical probity of the study, it is usually best to err on
the side of caution where there is uncertainty. Panel chairs are very happy to advise.
(Dr Martin Brinkworth, Chair, Biomedical, Natural and Physical Sciences Research Ethics Panel,
m.h.brinkworth@bradford.ac.uk, ext. 3584
Andy Scally, Chair, Humanities, Social and Health Sciences Research Ethics Panel,
a.j.scally@bradford.ac.uk, ext. 6431)
Please return Checklist to:
Lynda Nuttall, Ethics Administrator, Research Support Unit ,
Research and Knowledge Transfer Support, ext. 3170, [l.d.nuttall@bradford.ac.uk]
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